A STABLE GABAPENTIN FORMULATION SUPPRESSING PRODUCTION OF IMPURITIES AND PREPARATION PROCESS THEREOF

摘要

A method for preparing a gabapentin formulation is provided to obtain the stabilized gabapentin formulation where the generation of impurities is inhibited through spray-granulation technique. The method comprises the steps of: (a) mixing gabapentin with an excipient such as microcrystalline cellulose, copovidone, lowly-substituted hydroxypropylcellulose, lactose and starch so as to prepare a pre-mixture; (b) dissolving a binder such as hydroxypropylcellulose, hydroxypropyl methylcellulose, polyvinylpyrrolidine, copovidone and hydroxyethylcellulose and a stabilizer such as poloxamer and polyethylene glycol in alcohol to prepare a binding solution; and (c) spraying the binding solution into the pre-mixture.